Needle retraction apparatus

ABSTRACT

A needle retraction apparatus comprising a body having a forwardly projecting needle, a needle retraction mechanism seated inside the body and biasing the needle rearwardly relative to the body, a slide member attachable to the body and having an opening communicating with a needle retraction cavity projecting away from the body, and an actuator rotatable relative to the slide member to reposition the slide member from a first position preventing needle retraction to a second position permitting needle retraction. An IV catheter introducer comprising the subject needle retraction apparatus is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication No. 61/737,263, filed Dec. 14, 2012. This application is acontinuation of U.S. patent application Ser. No. 13/841,462, filed Mar.15, 2013, now U.S. Pat. No. 9,308,353, and is also a continuation-inpart of U.S. patent application Ser. No. 12/846,402, filed Jul. 29,2010, now U.S. Pat. No. 8,496,600.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a safety needle retraction apparatus formedical devices and, more particularly, to a new safety needleretraction apparatus that is part of a catheter introducer forintravenous or other biomedical applications, or as part of anotherdevice useful for other fluid infusion or collection procedures.

One aspect of the invention relates to an IV catheter introducer havinga needle retraction apparatus that is rotationally activated. Anotheraspect of the invention relates to a needle retraction apparatus for aglass or plastic liquid infusion or collection device, the apparatushaving a body, a needle retraction mechanism, and a forwardly facing,rearwardly biased needle.

Another aspect of the invention is a retractable needle apparatus thatis also adapted to be use with a conventional catheter hub and cannulathat are attachable to the front of the apparatus.

Another aspect of the invention relates to a rear slide assembly havinga flash chamber and a substantially parallel and laterally spaced-apartneedle retraction tube. The rear slide assembly is adapted to movetransversely relative to the body as the needle retraction tube isrotated relative to the body to initiate needle retraction followingfluid collection or infusion.

Another aspect of the invention relates to a method for retracting aneedle in a medical device whereby rotating a needle retraction tubecauses the needle retraction tube to be repositioned laterally intocoaxial alignment with a rearwardly biased needle to facilitateretraction of the needle into the needle retraction tube.

2. Description of Related Art

U.S. Publ. No. 2006/0155244 to Popov discloses a venipuncture devicethat rotates a port unit following needle retraction. The needleretraction chamber is disposed inside the medical device and remainsstable while the port unit is moved rotationally relative to theretraction chamber following needle retraction. The frontal attachmentdisclosed there cannot be used with a generic luer lock syringe.

Although many advancements in medical safety technology have been madein recent years, a retractable needle apparatus is needed that can beused in combination with other commercially available fluid collectionor infusion devices such as the IV-catheter introducer described here.Such a device will desirably have a needle retraction chamber externalto the fluid flow path and will offer the advantages of a retractableneedle having sufficient retraction force.

SUMMARY OF THE INVENTION

A needle retraction apparatus is disclosed that comprises a body, aslide member attachable to the rear of the body, a needle retractionmechanism seated inside the body, a fluid seal seated between the bodyand the slide member, and a medical grade stainless steel (or approvedequivalent) needle projecting forwardly from the body. According to oneembodiment of the invention, the body comprises a centrally disposed,stepped axial bore, laterally projecting gripping surfaces, and aforwardly projecting nose to which a conventional catheter hub andcannula are releasably attachable.

According to one embodiment of the invention, the slide member comprisesa forwardly facing surface that is configured to abut and movetransversely in slidable relation to the rear of the body during theneedle retraction process. In one embodiment, the rear of the bodycomprises upper and lower tracks that slidably engage the majortransverse portion of the slide member. The slide member desirablyfurther comprises two laterally spaced openings, one of which serves asan opening into a flash chamber projecting rearwardly behind theforwardly facing surface, and another of which serves as an opening fora rearwardly projecting needle retraction tube that is substantiallyparallel to but spaced laterally apart from the flash chamber.

The flash chamber is desirably aligned initially with the needle holder,and is preferably transparent or sufficiently translucent that medicalpersonnel using the device can readily determine whether vascular accesshas been achieved during insertion. A polymeric plug or other suitableapparatus is desirably installed at the rear of the flash chamber tofacilitate fluid infusion or collection through the flash chamber. Theplug can be pierceable or can be provided with a continuous bore tofacilitate connection to other fluid collection or infusion apparatus.

The needle retraction tube is desirably supported by the slide memberbut is rotatable in relation to the slide member to facilitate lateralrepositioning of the needle retraction tube during the needle retractionprocess. According to one embodiment of the invention, the needleretraction tube desirably has an open front end and a closed rear end,and comprises an annular flange disposed around the open end. Theannular flange preferably comprises a forwardly projecting lug that isreceived into a cooperatively aligned positioning notch in the bodyduring assembly. As the needle retraction tube is rotated to initiateneedle retraction, the forwardly projecting lug moves arcuately aroundthe longitudinal axis of the retraction tube and engages the sides ofthe repositioning notch in the body, which causes the slide member tomove transversely relative to the body, thereby placing the needleretraction tube in substantially coaxial alignment with the needleholder and needle.

According to one embodiment of the invention, the needle retractionmechanism comprises an elongate needle holder that is receivable intothe axial bore of the body and captures a compressed retraction springinside the body. Other similarly effective means for biasing the needleholder and needle rearwardly can also be used. The needle holder isdesirably restrained inside the body prior to needle retraction by thefacing and abutting slide member, and a fluid seal is desirably disposedbetween the rearwardly facing head of the needle holder and a forwardlyfacing annular recess in the opening into the flash chamber.

The needle retraction apparatus of the invention can be providedseparately from or in combination with the catheter hub, but isdesirably provided with the catheter hub already installed onto thebody. According to one satisfactory method of using the invention, theprotective cap (not shown) is removed from the front of the needle andcatheter hub, and with the forwardly projecting lug of the needleretraction tube positioning the flash chamber in substantially coaxialalignment with the needle holder and needle, the needle is inserted intoa patient. If blood appears in the flash chamber, this signifiessuccessful vascular insertion. The needle can be retracted from thecannula and into the apparatus by rotating the needle retraction tuberelative to the body to reposition the needle retraction tube intocoaxial alignment with the needle holder. Once the point of coaxialalignment is reached, the rearwardly biased needle holder is propelledrearwardly into a retraction cavity inside the needle retraction tube.At this point the catheter hub is available for connection to anotherapparatus such as an IV set.

BRIEF DESCRIPTION OF THE DRAWINGS

The apparatus of the invention is further described and explained inrelation to the following drawings wherein:

FIG. 1 is a top plan view of one embodiment of an apparatus of theinvention with the needle projecting forwardly from the needle hub ofthe apparatus in coaxial alignment with the flash chamber tube of theapparatus;

FIG. 2 is a side elevation view the embodiment of FIG. 1;

FIG. 3 is a cross-sectional side elevation view taken along line 3-3 ofFIG. 1;

FIG. 4 is an exploded front perspective view of the embodiment of FIG.1;

FIG. 5 is a cross-sectional top plan view of the embodiment of FIG. 1with following needle retraction and with the needle retraction tuberepositioned into coaxial alignment with the needle hub;

FIG. 6 is a side elevation view of the embodiment of FIG. 5; and

FIG. 7 is a cross-sectional side elevation of the embodiment of FIG. 1showing the needle holder and at least a portion of the needle andretraction spring retracted into the needle retraction cavity;

FIG. 8 is a rear elevation view of the apparatus of FIG. 1;

FIGS. 9 and 10 are rear elevation views of the of the apparatus of FIG.1 wherein the needle retraction tube has been rotated sufficiently tocause the rear slide assembly to begin repositioning the needleretraction tube into coaxial alignment with the needle holder; and

FIG. 11 is a rear elevation view of the apparatus of FIG. 1 with theneedle retraction tube fully repositioned to the retraction position.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1-4 disclose an IV catheter introducer 30 that comprises theneedle retraction apparatus of the invention, which further comprisesbody 34, forwardly projecting needle 78 (FIG. 4) with beveled tip 94,needle retraction mechanism 36, slide member 38, and needle retractiontube 42. Referring to FIGS. 1-4, catheter hub assembly 32 is aconventional IV catheter hub that is releasably attachable to body 34and includes a forwardly facing flexible sheath or cannula 44 throughwhich needle 78 is inserted to facilitate vascular insertion. Needleretraction mechanism 36 is seated inside body 34, and is held in placeby slide member 38 (FIG. 4) into which needle retraction tube 42 isinserted prior to being slidably engaged with the rear of body 34 duringassembly. It will also be appreciated by those of ordinary skill in theart upon reading this disclosure that the needle retraction apparatus ofthe invention is readily adaptable for use with other medical devices inwhich a retractable needle and a rotationally activated needleretraction mechanism are desired.

As depicted, catheter hub 32 further comprises hub nose 46 projectingforwardly from substantially cylindrical barrel 48 that also has a rearopening surrounded by annular attachment collar 50 comprising opposedlugs 52, 54. The inside of annular attachment collar 50 and barrel 48desirably comprises a tapered female luer surface configured to providefluid-tight frictional engagement with forwardly projecting male luertip 56 of body 34.

Body 34 comprises a stepped inside surface (FIG. 3) and has outsidegripping surfaces 58 desirably configured to be easily graspable by aclinician during vascular insertion. The rear portion of body 34preferably comprises laterally extending upper track 60 and lower track62 that are desirably configured to slidably engage and retain forwardlyfacing frame 80 of slide member 38 in close proximity to body 34. Apositioning notch 64 is desirably provided at the rear of body 34 tofacilitate engagement with forwardly projecting lug 102 of needleretraction tube 42 as further described below in relation to operationof the device.

Needle retraction mechanism 36 comprising needle holder 70 and spring 76(depicted in its compressed state to save space for illustrativepurposes in FIG. 4 rather than relaxed as shown in FIG. 7) is desirablyseated in the stepped cylindrical interior of body 34. Needle holder 70as shown comprises elongate cylindrical shaft 72 and a larger-diameterhead 74. The outside diameter of shaft 72 is desirably slightly lessthan the inside diameter of coiled spring 76 to permit insertion ofshaft 72 through the coiled spring. A continuous axial bore 92 desirablyextends through shaft 72 and head 74 of needle holder 70. The outsidediameter of head 74 is desirably sufficiently larger than that of shaft72 to provide a forwardly facing annular surface at the rear end ofshaft 72 against which the rear end of spring 76 abuts when compressedand installed inside body 34. The rearwardly facing end of the head 74of needle holder 70 can comprise a slight recess to facilitate seatingof fluid seal 68, although fluid seal 68 is desirably carried by slidemember 38 during needle retraction as discussed below. Compressed spring76 biases needle holder 70 rearwardly in relation to body 34, and needleholder 70 is retained inside body 34 against the spring bias by slidemember 38 when slide member 38 is assembled to body 34. Although spring76 is satisfactory for use in biasing needle holder rearwardly inrelation to body 34, other similarly effective configurations can alsobe used. During assembly of the subject needle retraction apparatus, therearwardly facing blunt end of needle 78 (FIG. 4) is desirably insertedinto bore 92 of needle holder 70 from the front and is attached in fixedrelation to needle holder 70 by any known suitable means, such as bygluing or the like.

Slide member 38 desirably comprises frame 80 and rearwardly projecting,substantially cylindrical fluid flash chamber 110 having an interiorspace into which fluid can flow from a patient through needle 78, needleholder 70 and aperture 90. Elastomeric plug 40 is desirably fitted intoa rearwardly facing opening of flash chamber 110. The forwardly facingportion of slide member 38 desirably comprises first and second circularopenings including apertures 90, 86, respectively. Opening 90 isprovided rearwardly of annular recess 88 in forwardly facing surface 84.Annular recess 88 is provided for seating fluid seal 68, which ispreferably an elastomeric O-ring disposed between head 74 of needleholder 70 and slide member 38 to prevent fluid leakage during use andprior to needle retraction. Aperture 86 is provided in recessed surfacesection 82 to facilitate assembly of needle retraction tube 42 withslide member 38.

Needle retraction tube 42 desirably comprises a first tubular section104 having a forwardly facing open end 98 surrounded by radiallyprojecting annular collar 100, and a second tubular section 108 having aclosed end 106 projecting away from body 34. The substantiallycylindrical interior space of needle retraction tube 42 serves as aretraction cavity. A plurality of ribs (or other similarly effectivesurface texturing) are desirably provided around section 108 tofacilitate gripping needle retraction tube 42 to rotate needleretraction tube 42 relative to body 34 to initiate needle retraction.Forwardly projecting lug 102 is desirably provided at the front ofneedle retraction tube 42, and is desirably cooperatively aligned withpositioning notch 64 in body 34. During assembly, needle retraction tube42 is desirably inserted into aperture 86 from the front of slide member38 so that tube 42 is rotatable around its longitudinal axis whenmounted in slide member 38 and so that the front face of annular collar100 (except for lug 102) is substantially flush with forwardly facingsurface 84 of slide member 38.

Referring to FIGS. 1-3, when IV catheter introducer 80 is fullyassembled, and ready for use (with the needle cap removed), beveledneedle tip 94 projects forwardly from cannula 44 and the centrallongitudinal axis of flash chamber 110 is aligned with the longitudinalaxis of the needle. Referring to FIGS. 5-7 and 8-11, when needleretraction tube 42 is rotated relative to body 34 as indicated by arrow114, the forwardly projecting lug 102 pushes against the side. ofpositioning notch 64 of body 34 and causes slide member 38 to sliderelative to body 34 in the direction indicated by arrow 118. As slidemember 38 moves laterally relative to body 34, fluid seal 68 (FIG. 4)disengages from head 74 of needle holder 70, eventually reaching theposition shown in FIGS. 5-7 and 11 wherein the central longitudinal axisthrough needle retraction tube 42 is aligned with needle holder 70.Because the diameter of front opening 98 of retraction tube 42 (FIG. 4)is slightly larger than the outside diameter of head 74 of needle holder70, the force of expanding spring 76 (FIG. 4) propels needle holder 70and needle 78 rearwardly into needle retraction tube 42.

Those of ordinary skill in the art will also appreciate upon readingthis specification and the description of preferred embodimentsdisclosed here that modifications and alterations to the apparatus andmethod of use can be made within the scope of the invention and it isintended that the scope of the invention be limited only by the broadestinterpretation of the appended claims to which the inventors are legallyentitled.

The invention claimed is:
 1. A needle retraction apparatus comprising: abody having a forwardly projecting needle; a needle retraction mechanismseated inside the body and biasing the needle rearwardly relative to thebody; a slide member disposed rearwardly of the body and attached inslidable engagement to the body and having a first opening communicatingwith a needle retraction cavity projecting away from the body; and aneedle retraction tube containing the needle retraction cavity, theneedle retraction tube being supported by the slide member and rotatablerelative to the slide member and the body to reposition the slide memberfrom a first position preventing needle retraction to a second positionpermitting needle retraction into the needle retraction cavity; whereinthe slide member is configured to move transversely relative to the bodybetween the first position and the second position.
 2. The needleretraction apparatus of claim 1 wherein the body further comprises aforwardly projecting luer tip.
 3. The needle retraction apparatus ofclaim 2 in combination with an IV catheter comprising a hub that isreleasably attached to the luer tip and a flexible cannula attached tothe hub through which the needle projects forwardly of the hub.
 4. Theneedle retraction apparatus of claim 1 wherein the needle retractionmechanism comprises a needle holder seated inside the body.
 5. Theneedle retraction apparatus of claim 4 wherein the needle is attached tothe needle holder and is biased rearwardly by a compressed needleretraction spring contacting the needle holder.
 6. The needle retractionapparatus of claim 1 wherein the body comprises spaced-apart tracks thatcooperate with the slide member to retain the slide member in closesliding engagement with the body.
 7. The needle retraction apparatus ofclaim 5 wherein the slide member further comprises a rearwardlyprojecting flash chamber and a second opening providing fluidcommunication between the needle holder and the flash chamber.
 8. Theneedle retraction apparatus of claim 7 wherein the rearwardly projectingflash chamber has a closed end that is distal to the second opening. 9.The needle retraction apparatus of claim 8 wherein the closed end of theflash chamber is blocked by an elastomeric plug.
 10. The needleretraction apparatus of claim 9 wherein the elastomeric plug ispenetrable by a cannula to establish a fluid path through the closed endof the flash chamber.
 11. The needle retraction apparatus of claim 1wherein the needle retraction tube is receivable through the firstopening in the slide member.
 12. The needle retraction apparatus ofclaim 11 wherein the needle retraction tube has an open end with and aclosed end, and a radially projecting annular flange around the open endthat has a diameter larger than the first opening of the slide memberand is supported in a forwardly facing recess in the slide member. 13.The needle retraction apparatus of claim 1 wherein the needle retractiontube comprises a projecting lug that engages a positioning notch in thebody.
 14. The needle retraction apparatus of claim 1 configured as anIV-catheter introducer.